The all about values, norms, correct and wrong,

The
aim of clinical research is to develop and establish knowledge to improve
health which valuable to society. Ethics of clinical study in the contact of
clinical research are all about values, norms, correct and wrong, good and bad
and which is must be done and must not be done. Investigators are responsible
for research ethics to ensure that there is no potential for exploitation and /or
abuse of human research subjects. Two significant events that have contributed
to the development of research ethics; a. Nazi experiments and Nuremberg Trial
1946, b. Tuskegee Syphilis study.

The
Belmont Report (1979), had come out with three important ethical principles
that had been accepted and used by worldwide. These 3 fundamental ethical
principles are; Respect for person, beneficence and non-malfeasance and lastly
is justice.

 

1.
Respect for person

Starting
from the participation, in the middle of the participation and until the
participation have ended, the person should be treated with respect and
equally. Respect for person who involve in the research means; the researcher
should inform the participants regarding all of the aspects related to the
study and participant’s decision to participate which means taking consent from
the participants. Other than that, researcher must protect participant’s
confidentiality and privacy and provide opportunity of early withdrawal without
penalty. Besides that, participants need to be monitored during and after the
trails, participants need to be informed regarding new information and details
and to re-take the consent if necessary. At the end of the study, the participants
should be informed the result of the study, compensate participants to research
injury, all of the information regarding clinical trial should be recorded,
handled and keep properly. The researcher must make sure the medical records
and data of subjects must be keep confidentially.

 

2.
Beneficence and non-malfeasance

Experiments need to be started and only can
be continued if the benefits are expected to justify the risk.
An assessment of risks and benefits of the research lies on the responsibility
of International Review Board (IRB) Independent Ethics Committee and before the
researcher embarking on that particular research.  In order to gain interest of science and
society, there are some important things to consider which are on the correct,
safety and well-being of the participants. Medical physicians or qualified medical
personnel should hold the responsibilities in giving medical care and medical
decisions made on behalf on the trial subjects. All trials must have
scientifically protocols to ensure research outcomes are accurate and
reproducible, researcher should provide adequate information regarding pre –
clinical and clinical, research conducted following and IRB approved protocols
and the products of investigational should be manufactured and used based on
Good Manufacturing Practice (GMP).

 

3.
Justice

Trial
subjects should be fairly selected. The selection of subject must be consider
of inclusion and exclusion criteria, target group as well as how to approach
them. Furthermore, the selection requires a clear scientific objectives
regarding the study, and not vulnerability, privilege, efficiency or other
factors unrelated to research purposes. Groups of trial subjects should be
aimed especially for risky study or study without advantages, which they are
convenient or vulnerable. 

 

Conclusion

These
three major ethical principles are the great tool use on the best ethical
practices that involved in research and to bring ethical awareness to their
thinking and decision – making.  

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